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Trial record 1 of 1 for:    NCT02877667
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Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol (SOL1601)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02877667
Recruitment Status : Completed
First Posted : August 24, 2016
Last Update Posted : July 29, 2020
MedSource LLC
Information provided by (Responsible Party):

Brief Summary:
Study of new acoustic wave device as an accessory to laser treatment in tattoo reduction.

Condition or disease Intervention/treatment Phase
Tattoo Device: planar acoustic wave device Not Applicable

Detailed Description:
A non-significant risk, single center, prospective device trial to evaluate the number of passes of Q-Switch laser treatment that can be completed with a Q-Switch Laser alone compared to use of the Soliton Planar Acoustic Wave Device System (AWD) System as an accessory to Q-switched laser in tattoo reduction treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Soliton Planar Acoustic Wave Device System for Dermal Clearing Human Trial Protocol
Study Start Date : July 2016
Actual Primary Completion Date : April 19, 2017
Actual Study Completion Date : April 30, 2017

Arm Intervention/treatment
Experimental: Open label device treatment
Up to four passes with Q-Switched laser alternating with acoustic wave device
Device: planar acoustic wave device
accessory to laser treatment
Other Name: AWD

Primary Outcome Measures :
  1. Demonstrate that multiple passes with Quality Switched Yag laser is safe based on assessment of Adverse Events [ Time Frame: 1 day ]
    Safety assessments included reported Adverse Events as a result of physician examination

Secondary Outcome Measures :
  1. Efficacy comparison of tattoo fading of laser versus laser and Acoustic Wave Device treated tattoos . [ Time Frame: 12 weeks ]

    The degree of fading assessed in terms of percentage fading (1-100%) and according to the following 1 to 5 scale:

    • 1 = 0%;
    • 2 = 1-25%;
    • 3 = 26-49%;
    • 4 = 50-75%; or
    • 5 = 76-100%

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Range of Fitzpatrick skin color scores I to III
  • Tattoo with location on arms, legs, and torso only, and accessible to AWD treatment head. Black ink only. Other ink colors may be present, but areas of black only tattoo should meet criteria described as: minimum 1" x 3" tattoo with at least 30-50% consistent coverage (see fig 1).
  • Tattoo age between 1 and 20 years.
  • Professionally applied.

Exclusion Criteria:

  • Subject is pregnant or planning to become pregnant during the duration of the study.
  • Prior tattoo removal procedures on target tattoo.
  • Self-applied or amateur tattoo.
  • Tattoo layering (additional tattoo placed over an older tattoo to hide it) on target tattoo.
  • Metal or plastic implants in the area of the tattoo (pacemaker, implanted defibrillator, stent, or implants in the hips, knees, elbows, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02877667

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United States, Massachusetts
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
MedSource LLC
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Study Director: Chris Capelli, MD Soliton
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Responsible Party: Soliton Identifier: NCT02877667    
Other Study ID Numbers: Soliton 2016-001
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Soliton: